Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters 2018

Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters 2018 is an event dedicated to the regulatory requirements for the Medical Device Quality System Regulations.

Topics

• Guidance document review, if any
• FDA Quality System requirements
• What to do:
• Review of Warning Letter citations
• Sampling plans/ship to stock/etc.
• Auditing activities (visits vs. surveys)
• Interactive Q&A Session
• Documentation of procedural controls/activities to demonstrate compliance

Who should Attend

• Regulatory Affairs Departments
• Quality Departments
• Production Departments
• Research & Development Departments
• Product Marketing Departments
• Quality Engineers
• Every professional involved with selecting and qualifying suppliers for a new device design